Electrical Engineer II Medical Devices

Ieee Ru Sb; Carlsbad, Northern (CA, KY); Hybrid; USD 85,000 - 115,000; Full time

Job summary

RESOLVEM Inc. is seeking an Electrical Engineer II in Irvine/Carlsbad, CA, on-site, with 3–5 years of hands-on electrical design and PCB ownership. You will drive schematic capture, board bring-up, and design documentation within a regulated medical-device oriented context.

You will collaborate across engineering disciplines, develop test fixtures, and mentor junior staff while maintaining DHF and ECO processes in a fast-paced environment.

Qualifications

• 3–5 years hands-on schematic capture and PCB design with ownership from concept to bring-up.
• Solid grounding in analog and digital circuit design and troubleshooting.
• Familiarity with BOMs, change orders, and design transfer in regulated environments.
• Experience with simulation tools such as LTspice/PSpice.

Responsibilities

• Lead schematic capture and PCB layout for analog, digital, power, and mixed-signal circuits.
• Own BOMs, ECOs, design revisions, and DHF traceability; ensure traceability for audits.
• Validate designs with LTspice/PSpice before hardware commitments.
• Develop test fixtures and automate data acquisition with Python or LabVIEW.
• Mentor junior engineers and collaborate across disciplines on projects.

Skills

Schematic capture

PCB design

Analog & digital design

LTspice

Python

C/C++

Signal integrity

DFMEA

Power electronics

Education

Bachelor's degree in Electrical Engineering

Tools

Altium Designer

OrCAD

PADS

KiCad

Job description

Electrical Engineer II:
RESOLVEM Inc. | Full-time | Mid-level

Local Candidates Only (Irvine, CA / Carlsbad, CA (On-site) with 3-5 years experience

About the job
At RESOLVEM Inc., you'll work across multiple medical device clients and product types, which means you'll accumulate range that engineers at a single-product company simply don't get. You'll take designs into actual field operation of medical line test equipment and medical products, drive root cause investigations when things fail, and grow into the engineer customers ask for by name.
Why RESOLVEM?
We're an engineering services firm specializing in R&D design support of new products and transferring product designs to design control and manufacturing. We help medical device companies bring their designs under design control, prepare them for mass manufacturing, and support their pilot manufacturing and transition to commercial-scale production. Because we work across multiple clients and products, you won't spend years on one subsystem. You'll build breadth and depth, fast, and you'll be trusted with real ownership from day one.

What you'll do
We'll be straight with you: this is regulated-industry work, and a real share of it is documentation. In medical devices paperwork is part of the product. An undocumented change is an unapproved change that could harm a patient. If that sounds like a chore rather than a craft, this isn't the right role. If you want to be an engineer whose design record holds up under an audit, read on.
Also, a board that works on the bench is not good enough. Our products are electromechanical systems, and you'll own how your design behaves inside the enclosure, on the harness, and inside the rest of the system. You will need to understand mechanical concepts, bills of materials, and how the electrical fits into a wider system.
Keep the design record airtight. You'll author and process Engineering Change Orders (ECOs) on behalf of customers, redline drawings and specifications, compare design revisions, maintain BOMs, purchasing specifications, and obsolescence plans, route changes through approval, and keep the Design History File current and traceable.
Own electrical designs. Lead schematic capture and PCB layout for analog, digital, power, and mixed-signal circuits, including sensor interfaces and microcontroller-based subsystems. Drive component selection, stack-up and layout strategy, signal integrity and power integrity considerations, and design-for-manufacturability/testability (DFM/DFT). Validate with LTspice/PSpice simulation before committing to hardware.
Take it from bring-up to production. Own board bring-up, debug, and characterization. Build custom benchtop test equipment and fixtures, and automate test and data acquisition with Python, MATLAB, or LabVIEW. Support design transfer, pilot builds, and the handoff to contract manufacturers.
Lead investigations. Drive electrical failure analysis and root cause analysis on complex issues. Author investigation reports, propose and verify corrective actions, and present findings to internal teams and customers.
Work fluently in the regulated world. Execute within a certified quality management system (ISO 13485, FDA 21 CFR 820) and design control processes. Own Design History File (DHF) deliverables and requirements traceability for your subsystems. Apply ISO 14971 risk management (DFMEA, hazard analysis), support IEC 62304 software lifecycle activities, and lead EMI/EMC design and pre-compliance testing toward IEC 60601-1-2 and IEC 60601-1 certification.
Own verification and validation. Define V&V strategy for your subsystems; author and execute protocols and reports; support test method validation (TMV), process development, inspection criteria, statistical data analysis, and equipment qualification (IQ/OQ/PQ).
Support firmware and system integration. Develop or guide firmware for microcontroller-based designs using C/C++ and protocols such as I2C, SPI, and UART, and integrate electrical subsystems with mechanical, software, and systems engineering.
Raise the team. Mentor interns and Electrical Engineer I staff, review their work, and serve as a technical point of contact for customers and contract manufacturers on assigned projects.

Local Candidates Only (Irvine, CA / Carlsbad, CA (On-site) with 3-5 years experience

You bring
Bachelor's degree in Electrical Engineering from an accredited university
Minimum of 3-5 years of hands-on experience in schematic capture and PCB design, with demonstrated ownership of boards from concept through fabrication and bring-up
Working understanding of mechanical and electromechanical systems: enclosures, connectors and cable harnesses, sensors, and thermal and vibration considerations, including the ability to read a mechanical drawing, reason about how a board fits and performs inside a real assembly, and work through fit, tolerance, grounding, and serviceability questions with mechanical engineers
Proficiency with PCB design software (Altium Designer preferred; OrCAD, PADS, or KiCad acceptable) and circuit simulation tools (LTspice, PSpice, or equivalent)
Strong benchtop skills: oscilloscopes, logic analyzers, spectrum analyzers, power meters, DMMs, and programmable supplies/loads
Solid grounding in analog and digital circuit design and troubleshooting, including power supplies, signal conditioning, and noise mitigation
Demonstrated experience leading electrical failure analysis and root cause investigations, including written reports
Proficiency in at least one of MATLAB, Python, or C/C++
Strong written and verbal technical communication; comfortable presenting in design reviews and to customers
Ability to work independently on moderately complex projects and to collaborate across disciplines

Bonus points for
Experience in a medical device or otherwise regulated environment (ISO 13485, FDA 21 CFR 820, design controls, DHF)
Working knowledge of IEC 60601-1, IEC 60601-1-2 (EMC), ISO 14971, and/or IEC 62304, IPC/WHMA-A-620
Experience taking a product through design transfer, pilot build, or EMC/safety certification
LabVIEW or automated test development experience
Familiarity with IPC standards, DFM/DFT practices, and working with contract manufacturers
Monday.com or similar project management tools; Agile/Scrum/Waterfall methodologies

The details
$85,000-$115,000/year depending on experience, education, and demonstrated skills (posted range complies with California pay transparency requirements, SB 1162)
Full-time, exempt position reporting to the Electrical and Systems Engineering Manager (R&D / Operations)
In-person in Irvine or Carlsbad, CA, 4-5 days per week, with up to 20% travel to customer and contract manufacturing sites
Must be legally authorized to work in the United States
Able to work for extended periods at the lab bench, handling small components with ESD-safe practices, occasionally lifting up to 25 lbs of test equipment
If you want to be the engineer who can take a medical device from napkin sketch to production line and own it the whole way, this is where you do it.

Local Candidates Only (Irvine, CA / Carlsbad, CA (On-site) with 3-5 years experience

RESOLVEM Inc. is an equal opportunity employer.